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Completed

NCT Number: NCT00991081

Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

The major purpose of this exploratory developmental study will be to develop a patient-centered and feasible protocol for communicating genetic data as it relates to drug efficacy for smoking cessation inpatients receiving medication that is matched to individual genotypes associated with increased efficacy for bupropion or nicotine replacement therapy.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SRI International, Menlo Park, California, United States

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About this study

Therefore, our specific aims are to:

Aim 1: Conduct formative research to develop and refine a clinical protocol for a multi-component smoking cessation intervention, grounded in the extended parallel process model, consisting of pharmacogenetic treatment (smoking cessation drug matched to each individual smoker's genotype) and genetic feedback (delivery of patient-centered, personalized genotype information and its predictive value for smoking cessation treatment efficacy): We will adapt, pilot-test, and refine a theoretically-grounded PGx smoking cessation intervention using formative interviews of 20 African-American and European-ancestry smokers.

Aim 2: Conduct a mixed-methods feasibility trial randomizing treatment-seeking smokers to pharmacogenetic (PGx) treatment combined with genetic feedback (GF) vs. PGx treatment without GF for smoking cessation to examine the feasibility of the newly developed protocol in a primary care setting and characterize its psychological and behavioral impact: Smokers (N = 100) will be randomized to GF vs. no GF and all will receive motivational interviewing (standard care/SC) and PGx treatment. We will assess the impact of GF on time to relapse, medication adherence, and a comprehensive assessment battery of process and cognitive, psychological, and behavioral outcomes. Finally, we will synthesize quantitative and qualitative data to revise protocols, generate hypothesizes, and estimate effect sizes for a follow-up R01 submission.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion and exclusion criteria are the same for participants in the formative interviews (Study A) and the feasibility RCT (Study B) except that Study A will include African American and European American smokers and Study B will include European American smokers.

Inclusion criteria

  • Adults (aged 18 or older)
  • Currently smoke at least 10 cigarettes per day
  • Motivated to quit smoking (>=5 on a 10-point Likert scale)
  • Have a telephone
  • Read and speak English.

Exclusion criteria

  • Any medical contraindications for transdermal nicotine replacement therapy (NRT) or sustained-release bupropion hydrochloride (bupropion) use based on the package labels (e.g., for bupropion, risk of seizure)
  • DSM-IV Axis I diagnosis (other than nicotine dependence)
  • Subjects who meet criteria for current major depression, or who demonstrate evidence of suicidal ideation at screening will be referred to treatment for depression and will be excluded from the study
  • Must agree not to seek other treatment for smoking cessation during the study.

Treatment and study plan

Counseling

Behavioral

Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling

  • One week prior to the target quit date (TQD)
  • Two weeks post-TQD
  • Four weeks post-TQD

Other names: Motivational interviewing, Motivational enhancement

Self-help guide

Behavioral

A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail

Other names: Support Materials, Clearing the Air

Pharmacotherapy

Drug

8-week course of genetically-tailored pharmacotherapy

  • Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
  • Participants with the A2 allele (CC) were assigned to receive bupropion

Other names: NRT, Nicotine Replacement Therapy, The Patch, Bupropion, Zyban, Aplenzin, Wellbutrin

Genetic feedback, verbal

Behavioral

During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment

Other names: Pharmacogenetics, Pharmacogenetic counseling

Genetic feedback, printed

Behavioral

After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype.

Other names: Pharmacogenetics, Pharmacogenetic Feedback

Primary outcomes

  1. Continuous Abstinence at 12 Weeks Post Target Quit Date

    Time frame: 12 weeks after Target Quit Date

    Participants reporting continuous tobacco-use abstinence 12 weeks after their Target Quit Date, whose salivary cotinine levels confirmed their abstinence, were counted as "abstinent." All others were recorded as not abstinent.

Secondary outcomes

  1. Morisky Adherence Scale

    Time frame: 12 weeks after Target Quit Date

    Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance

  2. Trust Scale

    Time frame: Within 1 week of first clinical call

    Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust

  3. Communication Scale

    Time frame: Within 1 week of first clinical call

    Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness

  4. Satisfaction Scale

    Time frame: Within 1 week of first clinical call

    Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction

  5. Treatment Interest Scale

    Time frame: Within 1 week of first clinical call

    Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest

  6. Depression

    Time frame: Within 1 week of first clinical call

    Category: Psychological Outcome Instrument: Center for Epidemiologic Studies Depression Scale (CES-D) Measures: Interest in participating in recommended treatment plan Range: 0-60 Direction: Higher values represent increased symptoms of depression

  7. Fatalism

    Time frame: 12 weeks after Target Quit Date

    Category: Psychological Outcome Instrument: Powe Fatalism Inventory, 10-item, revised Measures: belief in inevitability of smoking status Range: 0-10 Direction: Higher values represent increased fatalism beliefs

  8. Intention to Quit

    Time frame: Within 1 week of first clinical call

    Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Intention, confidence, and expectation of quitting smoking Range: 3-21 Direction: Higher values represent increased intention to quit

  9. Motivation

    Time frame: Within 1 week of first clinical call

    Category: Psychological Outcome Instrument: Single item, Likert scale from 1 to 7 Measures: Desire to quit smoking Range: 1-7 Direction: Higher values represent increased motivation to quit

  10. Perceived Control

    Time frame: Within 1 week of first clinical call

    Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Control over ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased sense of control

  11. Risk Perception

    Time frame: Within 1 week of first clinical call

    Category: Psychological Outcome Instrument: 4-item inventory, Likert scale from 1 to 5 Measures: Perceived personal health risks from smoking Range: 4-20 Direction: Higher values represent increased perception of risk

  12. Self-Efficacy

    Time frame: Within 1 week of first clinical call

    Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Perceived ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased self-efficacy

  13. Threat Minimization

    Time frame: Within 1 week of first clinical call

    Category: Psychological Outcome Instrument: 2-item inventory, Likert scale from 1 to 7 Measures: Perceived presence of factors that would reduce personal smoking risks Range: 2-14 Direction: Higher values represent increased risk minimization

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Johns Hopkins University
  • National Institute on Drug Abuse (NIDA)
  • SRI International
  • University of Bristol

Registry information

Official study title

Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2009
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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